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Anticoagulant

Enoxaparin Dosing Regimens for Blood Clots

Phase 4
Recruiting
Led By Martin A Schreiber, MD
Research Sponsored by Oregon Health and Science University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Admitted patients requiring prophylactic dosing of enoxaparin (Lovenox)
Age greater than 15 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up daily, up to day 90
Awards & highlights

Study Summary

This trial will help determine if a lower dose of enoxaparin given twice daily is as effective as the standard dose of enoxaparin given once daily in preventing blood clots in critically ill patients.

Who is the study for?
This trial is for patients over 15 years old who are at risk of blood clots and need preventive treatment with enoxaparin after trauma or surgery. It's not for those who can't consent, already on a full dose of enoxaparin, using other anticoagulants, have kidney failure needing special doses, or have bleeding in the brain.Check my eligibility
What is being tested?
The study compares two dosing schedules of enoxaparin: one group receives 30 mg twice daily while another gets 40 mg once daily. The goal is to see which dosage better prevents blood clots without increasing bleeding risks in critical care patients.See study design
What are the potential side effects?
Enoxaparin may cause side effects like bleeding complications, irritation at the injection site, low platelet counts (which helps your blood clot), and allergic reactions. Monitoring will be done to detect these issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am in the hospital and need preventive blood clot medication.
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I am older than 15 years.
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I am currently admitted under the care of a trauma or surgical team.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~daily, up to day 90
This trial's timeline: 3 weeks for screening, Varies for treatment, and daily, up to day 90 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Thromboembolic events
Secondary outcome measures
Increase in bleeding complications

Trial Design

2Treatment groups
Active Control
Group I: Enoxaparin Sodium Injection 30 mg BIDActive Control1 Intervention
Subjects are randomized to receive 30 mg twice daily of enoxaparin.
Group II: Enoxaparin Sodium Injection 40 mg QDActive Control1 Intervention
Subjects are randomized to receive 40 mg once daily of enoxaparin.

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Who is running the clinical trial?

Oregon Health and Science UniversityLead Sponsor
980 Previous Clinical Trials
7,386,116 Total Patients Enrolled
1 Trials studying Thromboembolism
Martin A Schreiber, MDPrincipal Investigator - Oregon Health and Science University
Oregon Health and Science University
1 Previous Clinical Trials
166 Total Patients Enrolled
~28 spots leftby Dec 2024
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